FDA 510(k)

Admiral Xtreme

Número K: K173515 · 2018-04-12

Data da decisão2018-04-12

Código do produtoLIT

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Admiral Xtreme is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 2018-04-12 under 510(k) number K173515. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Admiral Xtreme?

Admiral Xtreme is a medical device that received FDA 510(k) clearance on 2018-04-12. The listed applicant is Medtronic Vascular. The 510(k) number is K173515.

When did Admiral Xtreme receive FDA 510(k) clearance?

Admiral Xtreme received FDA 510(k) clearance on 2018-04-12, under 510(k) number K173515.

Who is the listed applicant for Admiral Xtreme?

The FDA 510(k) record lists Medtronic Vascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Admiral Xtreme?

The FDA product code for Admiral Xtreme is LIT.

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